Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment

Summary

The purpose of this study is to evaluate the effect of patient outreach program on the
proportion of time patients with MTC experience moderate or severe AEs during first 12
months of treatment with vandetanib

Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner

vandetanib

Treatment 300mg vandetanib opel label.

Primary Outcomes

Measure

Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.

time frame:
12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged 18 years and over
- Previously confirmed histological diagnosis of unresectable, locally advanced or
metastatic hereditary or sporadic MTC. Documentation must be provided in patient's
medical chart
- WHO or ECOG Performance status 0-2
- Negative pregnancy test (urine or serum) for female patients of childbearing
potential
Exclusion Criteria:
- Unstable brain metastases or spinal cord compression that require treatment, unless
treated at least 4 weeks before first dose and stable without steroid treatment for
10 days
- Major surgery within 4 weeks before randomization
- The last dose of prior chemotherapy received less than 3 weeks prior to randomization
- Radiation therapy not completed prior to the first dose of vandetanib
- Significant cardiac event, superior vena cava syndrome, NYHA classification of heart
disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that
in the opinion of the Investigator increases risk of ventricular arrhythmia
- Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with
moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must
start vandetanib at a reduced dose of 200 mg

Additional Information

Official title

A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib

Principal investigator

Lars Bastholt, MD DPM

Trial information was received from ClinicalTrials.gov and was last updated in September 2015.

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Trial Details

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